N/A
Completed N=200
The Wise App Trial for Improving Health Outcomes in PLWH
Source: ClinicalTrials.gov NCT03205982 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Change in ART Adherence - Clever Cap — 0.385; 0.445 Times taking medication/day — p=<0.0001
Summary
The overall goal of this study is to design a user-centered design app linked to a smart pill box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a strong theoretical framework building on earlier user-centered design work and integrating a real-time monitoring device, this work has the potential to improve ART adherence in PLWH and have a sustainable public health impact.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in ART Adherence - Clever Cap |
0.385; 0.445 | <0.0001 sig |
| SECONDARY Change in Score on the Center for Adherence Support Evaluation (CASE) Index |
9.099; 8.557; 10.667; 10.099; 10.714; 10.197 | — |
| SECONDARY Change in Cluster of Differentiation 4 (CD4) Count |
5.972; 6.060; 5.811; 6.102; 5.772; 5.974 | — |
| SECONDARY Change in Viral Load |
0.634; 0.567; 0.536; 0.444; 0.558; 0.5 | — |
| SECONDARY Change in Number of Primary Care Visits |
1.153; 1.084; 1.207; 1.111; 1.208; 1.24 | — |
| SECONDARY Change in Score on the Engagement With Health Care Provider Scale |
17.386; 18.186; 16.607; 18.038; 18.221; 18.039 | — |
| SECONDARY Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire |
2.053; 2.044; 1.807; 1.762; 1.861; 1.692 | — |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of HIV
- Report past 30 days adherence of 80% or less as measured using the Visual Analogue Scale (VAS), or have a viral load of over 400 copies/mL
- Be able to communicate and read in English or Spanish
- Live in the US
- Have a smartphone
- Be taking ART medications
Exclusion Criteria
- Participation in any other mobile app study for PLWH, including text messaging studies
- Diagnosis of a clinical problem that would preclude someone from using a smartphone
Data sourced from ClinicalTrials.gov (NCT03205982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.